Chronic Heart FailurePhase 2NCT00057356
Safety and Efficacy Study of YM087 (Conivaptan) in Patients With Acute Decompensated Heart Failure
A Phase 2 study testing conivaptan in people with Chronic Heart Failure, run by Cumberland Pharmaceuticals at 26 sites in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine the effects of conivaptan in patients with acute decompensated heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- conivaptan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 26 sitesUnited States
- Study dates
- Nov 2002to Mar 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be male or female age 18 years or older.
- Women must be post-menopausal or surgically sterile.
- Patients must have chronic heart failure of at least 2 months duration and be hospitalized for the treatment of worsening heart failure. The primary manifestation of worsening heart failure must be worsening dyspnea.
Who cannot join
None listed.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
University of Maryland Hospital
Baltimore, Maryland, 20201
Medical University of South Carolina
Charleston, South Carolina, 29425
Rush-Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612
University of Cincinnati, College of Medicine, Div. of Cardiology
Cincinnati, Ohio, 45267
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University Medical Center, Heart and Lung Research Institute
Columbus, Ohio, 43210
Cardiovascular Research Institute of Dallas
Dallas, Texas, 75231
The Greater Fort Lauderdale Heart Group Research
Fort Lauderdale, Florida, 33308
Hershey Medical Center
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
The Heart Center, P.C.
Huntsville, Alabama, 35801
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
LA County/USC Medical Center
Los Angeles, California, 90033
San Joaquin Cardiology
Manteca, California, 95337
Baptist Clinical Research
Memphis, Tennessee, 38120
U. Miami, Jackson Mem'l Medical Center
Miami, Florida, 33136
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Louisiana State University Medical Center School of Medicine
New Orleans, Louisiana, 70112
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119
New York Presbyterian Hosp, Milstein Hosp.
New York, New York, 10032
Discovery Medical Research Group
Ocala, Florida, 34478
Apex Research Institute
Santa Ana, California, 92705
University of Washington
Seattle, Washington, 98195
Cardiac Centers of Louisiana, LLC
Shreveport, Louisiana, 71103
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging Pilot Study Evaluating the Efficacy and Safety of YM087 in Patients With Decompensated Chronic Heart Failure
This is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine the effects of conivaptan in patients with acute decompensated heart failure.
- Conditions
- Chronic Heart Failure
- Being tested
- conivaptan, placebo
- Keywords
- Chronic Heart Failure, YM078
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conivaptanDrug
Also called Vaprisol, YM087
IV
placeboDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: placebo |
| 2 | Experimental | Low dose Receives: Drug: conivaptan |
| 3 | Experimental | Middle dose Receives: Drug: conivaptan |
| 4 | Experimental | High dose Receives: Drug: conivaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in respiratory Visual analog Scale (VAS)
Measured: 48 hours
Secondary outcomes (2)
Change from baseline in global VAS
Measured: 48 hours
Total urine output vs. baseline
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2003 (estimated)
- Study startNov 2002
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Art Wheeler, MD, Study director, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057356
- Sponsor's protocol ID
- 087-CL-071
- Status last verified
- Apr 2014
- First submitted
- 31 Mar 2003
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-ranging Pilot Study Evaluating the Efficacy and Safety of YM087 in Patients With Decompensated Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00057356
- Acronym / sponsor ID
- 087-CL-071
- Conditions
- Chronic Heart Failure
- Keywords
- Chronic Heart Failure, YM078
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 1 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine the effects of conivaptan in patients with acute decompensated heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placebo |
| 2 | Experimental | Drug: conivaptanLow dose |
| 3 | Experimental | Drug: conivaptanMiddle dose |
| 4 | Experimental | Drug: conivaptanHigh dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients may be male or female age 18 years or older.
- Women must be post-menopausal or surgically sterile.
- Patients must have chronic heart failure of at least 2 months duration and be hospitalized for the treatment of worsening heart failure. The primary manifestation of worsening heart failure must be worsening dyspnea.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conivaptanAlso: Vaprisol, YM087IV | Drug | 2, 3, 4 |
| placeboIV | Drug | 1 |
Primary outcome
Change from baseline in respiratory Visual analog Scale (VAS)
Time frame: 48 hours
2 secondary outcomes
Change from baseline in global VAS
Time frame: 48 hours
Total urine output vs. baseline
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Art Wheeler, MD study director
Cumberland Pharmaceuticals
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing conivaptan in people with Chronic Heart Failure, run by Cumberland Pharmaceuticals at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in respiratory Visual analog Scale (VAS) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2014.